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Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Sponsor: University Hospital, Lille
Summary
Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.
Official title: A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2013-07-09
Completion Date
2016-04-17
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
Freezed-dried plasma
early transfusion of 4 units of freezed dried plasma
Fresh-frozen plasma
Locations (1)
Emergency unit, Salengro hospital,
Lille, France